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04 February 2012
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| [ Print-friendly version ] |
| Early External Cephalic Version (ECV) 2 trial |
| ISRCTN | ISRCTN56498577 |
| ClinicalTrials.gov identifier | NCT00141687 |
| Public title | Early External Cephalic Version (ECV) 2 trial |
| Scientific title | |
| Acronym | EECV2 |
| Serial number at source | MCT-65630 |
| Study hypothesis |
1. For women with a foetus in breech presentation, does early External Cephalic Version (ECV) (at 34^0/7 - 35^6/7 weeks) versus delayed ECV (not before 37^0/7 weeks) increase or decrease the likelihood of Caesarean Section (CS)?
2. Is the risk of preterm birth (less than 37^0/7 weeks) lower or higher with early versus delayed ECV? |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Ethics approval received from
1. The University of British Columbia Clinical Research Ethics Board on the 18th August 2004 (ref. no.: C04-0348), amendment on 6th October 2004 2. Research Ethics Board of Hamilton Health Sciences Research Ethics Board on the 20th March 2007 (ref: 07-122) (added to the record on 08/11/2007) |
| Study design | Randomised controlled trial |
| Countries of recruitment | International |
| Disease/condition/study domain | Pregnancies with a foetus in breech presentation |
| Participants - inclusion criteria |
1. Women with any breech presentation, aged 18 - 49 years old
2. A live singleton foetus 3. Gestational age of 33^0/7 - 35^6/7 weeks |
| Participants - exclusion criteria |
1. Any contraindication to ECV
2. Previous participation in the EECV2 Trial 3. Any contraindication to early ECV 4. Women who wish a vaginal delivery if the foetus remains breech 5. Any contraindication to labour or vaginal birth 6. Women who wish to deliver by Caesarean Section (CS) if the foetus turns to cephalic 7. Women at increased risk of unstable lie Please note that the following exclusion criteria was removed from this list on 06/11/2007: 8. Women who plan to move to a non-trial centre prior to delivery |
| Anticipated start date | 01/12/2004 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Completed |
| Patient information material | EECV2 trial information for Parents and Families available on http://www.utoronto.ca/cmicr/eecv2/pat/index.htm |
| Target number of participants | 1460 women (730 per group) are required. Recruitment complete as of July 2008. |
| Interventions |
Women will be randomised to have either an early ECV at 34 - 35 weeks gestation, or a delayed ECV at or after 37 weeks gestation
As of 1st January 2007 the sponsor changed from the Canadian Institutes of Health Research (CIHR) to the current sponsor, the McMaster University Medical Centre (see below). |
| Primary outcome measure(s) |
Rate of CS.
Outcomes will be measured at two planned interim analyses: 1. After 500 participants were recruited (analysis complete 02/2007) 2. After 900 participants were recruited (analysis expected to be complete 01/2008) 3. After the full sample of 1460 participants have been recruited |
| Secondary outcome measure(s) |
1. Rate of preterm birth
2. Other outcomes include admission to neonatal intensive care unit more than or equal to 24 hours, perinatal or neonatal mortality or serious neonatal morbidity, serious foetal complications, maternal death or serious maternal morbidity, non-cephalic presentation at birth, women’s views, and health care costs Outcomes will be measured at two planned interim analyses: 1. After 500 participants were recruited (analysis complete 02/2007) 2. After 900 participants were recruited (analysis expected to be complete 01/2008) 3. After the full sample of 1460 participants have been recruited |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-65630) |
| Trial website | http://www.utoronto.ca/cmicr/eecv2/ |
| Publications | 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21291506 |
| Contact name | Dr Eileen Hutton |
| Address |
Department of Obstetrics and Gynecology
McMaster University 1200 Main Street West, MDCL 3103 |
| City/town | Hamilton, Ontario |
| Zip/Postcode | L8N 3Z5 |
| Country | Canada |
| Tel | +1 905 525 9140 ext. 26654 |
| Fax | +1 905 523 6459 |
| huttone@mcmaster.ca | |
| Sponsor | McMaster University Medical Centre (Canada) |
| Address |
c/o Sarah Lampson
Clinical Trial Agreements and Contracts Specialist 1057 Main Street West Suite 1, Room 103 |
| City/town | Hamilton, Ontario |
| Zip/Postcode | L8S 1B7 |
| Country | Canada |
| Tel | +1 905 521 2100 |
| Fax | +1 905 577 8379 |
| lampson@hhsc.ca | |
| Date applied | 19/04/2004 |
| Last edited | 04/07/2011 |
| Date ISRCTN assigned | 22/04/2005 |
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